A Study of the Value of Diagnostic Cervical Conization for Persistent Infection or Integration of Human Papillomavirus
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- The incidence of discovering concealed cervical cancer or percancerous lesions
研究概览
简要总结
For the patients with cervical persistent infection or integration of HPV, we has designed a program to perform cervical conization for certain patients to earlier and better diagnose and cure the diseases of HPV infection and related cervical intraepithelial neoplasia/cancer.
详细描述
For the patients with cervical persistent infection or integration of human papillomavirus, the incidence of suffering cervical cancer or percancerous lesions increases. As the biopsy guided by colposcopy might miss some lesions, the cervical conization plays a role for the patients with high risk factors to diagnose the related cervical diseases. In this study, we has designed a program to perform cervical conization for certain patients to earlier and better diagnose and cure the diseases of HPV infection and related cervical intraepithelial neoplasia/cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The patients are referred to colposcopy and biopsy examinations due to abnormal cervical screening results with no precancerous lesions discovered by pathology.
- •The cervical precancerous lesions are highly suspected by clinicians with one or more following risk factors:
- •The course of HPV type 16/18 persistent infection is more than two years.
- •The integration reads of HPV is more than
- •The impression of colposcopy indicates precancerous lesions.
- •The cervical TCT indicates ASC-H/HSIL/SCC/AGC-FN/AIS/AC.
排除标准
- •Pregnant women.
- •Vaginal intraepithelial neoplasia is highly suspected by colposcopy and pathological examinations.
- •The patients are suffering malignant tumors of other system and have not been cured.
- •There is acute inflammation of the lower genital or anal tract.
- •The patients' health will be severely harmed by the colposcopy and cervical conization due to some circumstances such as severe insufficiency of liver and kidney function, blood diseases and acute inflammation of other systems.
研究组 & 干预措施
Patients
The patients who meet the inclusion criteria will receive diagnostic cervical conization for pathological examinations. Then they will be followed up for at least two years with every six months' return to our clinics to test HPV and colposcopy if necessary.
干预措施: diagnostic cervical conization (Procedure)
结局指标
主要结局
The incidence of discovering concealed cervical cancer or percancerous lesions
时间窗: up to 2 months after recruited
The pathological examinations of the cervical conization might discover some concealed cervical cancer or precancerous lesions which could not be discovered by biopsy guided by colposcopy.
The incidence of HPV clearance after the cervical conization
时间窗: Through the study completion, an average of 3~5 years
After the cervical conizations, the patients will be arranged for follow-up every six months and HPV will be tested to see if the virus is cleared or not
次要结局
未报告次要终点